The arrival of the Omicron variant confirms that it will be impossible for us to emerge from this pandemic without ensuring equitable access to vaccines in developing countries. Experts said it at the very beginning of the pandemic …
According to many, the lifting of patents is the solution to advocate. South Africa and India made a request to the countries of the World Trade Organization in October 2020 when several developing countries, unlike Western countries, could not make advance purchases of vaccines in because of their excessively high prices.
Necessarily, granting the lifting of patents would have the effect of setting an important precedent in terms of the non-recognition of intellectual property rights in the context of a pandemic. Adhering to this option must therefore be made with a thorough knowledge of what it implies. I am trying here to highlight the nuances that are essential.
The purpose of patents
Patents are intellectual property rights which give the patent holder exclusive marketing rights for a period of 20 years following the filing of his patent application. The latter were created in order to encourage investment in research and development: it is anticipated that the inventor will have a greater interest in investing in research if he knows that he will be able to recover the cost of his investment, not only linked to the development of his commercialized invention, but also linked to all the research he carried out and which proved to be unsuccessful. In general, it is accepted that for every 10,000 molecules identified in the fundamental research phase, only one will pass the commercialization stage.
The example of South Africa not applicable
The request presented by South Africa and India is not limited to patents, but to all intellectual property rights relating to vaccines (eg: trade secrets, clinical data, etc.). Accepting it would set an important precedent for the violation of intellectual property rights.
Some have referred to the example of South Africa which, at the end of the 1990s, had included in its law a compulsory license fee in order to have access to generic drugs (cheaper than patented drugs). to ensure that its population has access to drugs to treat HIV / AIDS. The move prompted 39 pharmaceutical companies to sue the government alleging infringement of their patent rights. This lawsuit had the effect, and rightly so, of arousing indignation on the international scene, thus pushing companies to abandon their legal action, their reputation being heavily tarnished.
Ultimately, however, it is important to realize that South Africa never felt the need to issue compulsory licenses, as the drugs for HIV / AIDS were eventually channeled more appreciably thereafter.
Furthermore, it should be noted that international agreements allow countries, in the context of a public health emergency, to issue compulsory licenses.
These are distinguished from the lifting of patents: they consist of the granting of forced contracts where the patent owner grants a third party the right to exploit and sell his invention for an exchange of reasonable royalties. Patents remain valid and enforceable in all countries that have not issued compulsory licenses. The effect is therefore local.
Some would say that it can be difficult to get a compulsory license. Several laws require that an effort be made to obtain a voluntary license first. However, countries can change their laws, as Canada did in a few months at the start of the pandemic, specifically to facilitate access to compulsory licenses if the need arose.
Others will point out that countries do not have the manufacturing capacity to produce their own vaccines. It’s true. It is for this reason that, following the Doha Declaration in 2001, developed countries provided for in their law the possibility of issuing compulsory licenses for the purpose of exports. Canada, with “Jean Chrétien’s Commitment to Africa”, was the first country to follow suit. However, it must be admitted that the mechanism provided for in Canada is particularly complex so that it has only been used once for the production of Apo-TriAvir intended for Rwanda.
No guarantee
Unlike the start of the pandemic, vaccines are less scarce in developing countries which, excluding donations from China, have received over 2.5 billion doses (including Pfizer and Moderna) from United States, European Union countries and Canada.
At the end of November 2021, the World Health Organization reported that the delays in vaccination, particularly in African countries, are now the result of a significant reluctance of the population of these countries to get vaccinated, including from health professionals. The countries of Africa, being already, in most cases, struggling with precarious health infrastructures, thus find themselves with a lack of health professionals authorized to vaccinate.
Result: India and South Africa have announced that they may have too many vaccines, being unable to use up their reserves.
In short, the lifting of patents should not be presented as THE solution that will allow us to get out of the pandemic. It is important to be transparent about the risk it entails of chilling research investments during a next pandemic. Moreover, we must be lucid and recognize that at this time of the pandemic, this solution will not be sufficient. It is essential to strengthen the health systems of developing countries. It will necessarily be understood that, for the future, an international agreement, involving the industry, which must adhere to the principle of social responsibility, is essential to ensure rapid and equitable access to vaccines and drugs in the context of a pandemic.
* The author is a full professor in health law and policy at the University of Sherbrooke. She served as a visiting scholar with the Medical Research Council in South Africa and as a patent policy analyst for the federal government during the development of Jean Chrétien’s Commitment to Africa.